Yesterday, the House Energy and Commerce Subcommittee on Health heard from FDA Deputy Commissioner Joshua Sharfstein on the safety of the drug supply and current agency practices to ensure the safety of marketed drugs.

Sharfstein, who has been a strong advocate for drug safety, both at the agency and previously  as health commissioner in Baltimore, made a forceful case for what FDA needs to keep drugs safe: “FDA needs additional tools to move our oversight capabilities into the 21st century.  FDA needs to access regulatory information quickly, hold all parties responsible for the quality of products in the supply chain, and have reasonable and reliable options for enforcement,” he said.

The hearing was notable for the bipartisan consensus that securing the safety of the drug supply is a national priority with high stakes, and unanimous agreement that the FDA’s ability to ensure that safety must be shored up. It convincingly framed drug safety as an equally urgent next step to a food safety measure that passed the House by a wide margin last year.

But perhaps the hearing’s most compelling arguments for a safer drug supply came in this stage-worthy exchange between Sharfstein (JS) and Chairman Emeritus John Dingell (JD), who has worked to support the agency’s drug safety efforts for much of his recent career.

JD: Dr. Sharfstein, I want you to understand these are friendly questions. I want yes or no answers. You are familiar with the heparin crisis, which caused 81 American deaths. Does FDA currently have the adequate resources, personnel, and authorities to prevent another heparin crisis?

JS: No.

JD: Do you have the ability to control the safety of imported pharmaceuticals?

JS: Not to the extent we’d like.

JD: Do you have the authority and resources to address the safety of components being now imported into this country?

JS: No, not to the extent we’d like.

JD: Do you have authorities and resources to see to it that good manufacturing practices (GMPs) are properly observed overseas?

JS: Not to the extent we’d like.

JD: Would you please submit to the committee the number of people that you have at the different ports to ensure the safety and the inspection of pharmaceuticals coming into this country, and also would you give the number you need to see that this is done. Please submit that for the record.

[JS assents]

JD: Do you have adequate authority to keep out unsafe drug shipments at the border?

JS: No.

JD: Do you have authority to require manufacturers to ensure the safety of their supply chain?

JS: No.

JD: Do you have the authority to see to it that GMP are observed in this country on both food and drugs, and abroad? Yes or no?

JS: No, not to the extent we’d like.

…
JD : Do you have adequate authority to require mandatory drug recalls?

JS: No.

JD: Do you need that authority?

JS: We would like it that authority, yes.

JD: Would you like it or do you need it?

JS: I’d say we need it.

JD: [refers to the Food and Drug Administration Globalization Act of 2009 and its cosponsors] [FDAGA] would give you significant authorities to address your current lack of capabilities?

JS: That legislation has very important elements, yes.

JD: It would also give you the [financial resources] you need by enabling you to collect fees from both manufacturers of food and pharmaceuticals? Is that right?

JS: It does have that provision, yes.

JD: And you can do that both at home and abroad, is that right?

JS: I believe so, yes.

JD: Are those resources and fees included in your budget submissions to the Congress?

…

JS: For food it is.

JD: How about pharmaceuticals?

JS: I don’t believe so, no.

JD: Now it’s a curious situation I’ve observed, that you are in the awkward place at FDA of having somebody be able to bring unsafe foods into the United States, and you can’t catch them at the point of entry. But you also have the problem that if you do catch them, you don’t have authority to seize, impound or to destroy. Is that right?

JS: Yes.

JD: So you send them back out?

JS: I believe so. Often that’s what happens.

JD: And they then often bring them back in, through another point of entry?

JS: I think they can try, yes.

JD: Do you have that same problem with pharmaceuticals?

JS: Yes.

JD: So that problem exists in both places. So you have problems with unsafe commodities being brought in—foods and pharmaceuticals. You also have some that are over-aged, improperly stored, contaminated, filthy, improperly packaged. Counterfeit. And you also have some that are full of inert substances, you mentioned talcum powder…Do you have authority to deal with those?

JS: We have some authorities. But not–

JD [interrupts] Do you have enough?

JS: We don’t have enough.

JD: As proven by heparin.

JS: Yes, in part.

JD: And you have coming into this country from China on a fairly regular basis—and from Mexico and other places—unsafe food and pharmaceuticals. I can recall mushrooms. I can recall berries. I can recall tomatoes and jalapeno peppers. I can recall the heparin scare. And a large number of others. This is an ongoing and continuous problem, is it not?

JS: Absolutely.

JD: And you lack the Congressional support, both in authority and money, to do the job that you need to do to protect the American people? Isn’t that right?

JS: Well, we very much want to do more.

JD: I don’t want you to be afraid to say that we haven’t given you  the authority you need—

JS:  No we want more authority—

JD: —If it’s the truth, because we’re going to try to get it for you.

–Kate Petersen, PostScript blogger

Sneak preview: This afternoon, the House Energy and Commerce subcommittee on Health will hear from FDA Deputy Commissioner Joshua Sharfstein and other agency officials at the first drug safety hearing since the new administration took office. We’ll have more on what Commissioner Sharfstein has to say later this afternoon.

In other FDA buzz,  Mark Senak at Eye on FDA says that shifts in web referral traffic–Facebook now tops Google as the top referring site—underscores the power shift toward social media on the web:

The emergence of Facebook as a driver of traffic signals an important shift in the way that people are getting and consuming information.  More than ever, the idea of referral from a contact is taking up a huge proportion of the spectrum.  That means that for any message – whether it is product related, or public health related – to gain traction, you have to do more than build a Web site and wait for people to discover it.  You have to have a Facebook presence.

Mr. Senak, who consults industry on communications, points to some of the problems of a regulated industry participating in a space as splintered and unregulated as Facebook and Twitter, when it’s not always clear who’s doing the talking. He says FDA should be on Facebook. But it’s not clear exactly what he wants the agency to do once it gets there – serve in an ombudsman or watchdog role? or actively engage with consumers and those in the pharma community? Just avert the “Risk of Ignoring”? In a previous post, he suggests that Facebook would provide a good portal to agency resources, and that may be so, but he leaves aside the important question of how the FDA might protect public health in that space.

This is part of a larger conversation about how pharma and medical device companies operate on the internet – an act which, we note, is a form of marketing. The FDA is charged with regulating the marketing of approved prescription drugs and devices.

In November, the agency invited the public to weigh in on how the agency can uphold its mission to protect the public health as companies move more and more of their marketing resources and attentions to the internet. Community Catalyst and the Pew Prescription Project urged FDA to proceed with caution—and until there is good evidence of public health benefits and comprehension of risks in online venues, existing rules about how companies talk to consumers and what they say should not be bent or relaxed.

But Senak detracts from his call for FDA to “be there” by urging companies not to wait for rules or guidance, suggesting that those who wait to understand the parameters of online marketing do so at their peril.

And so as FDA slowly grapples with its increasingly complex task of developing some guidance around social media – an environment that is constantly evolving at breakneck speed – the agency needs to consider how people are in fact communicating today and companies need to decide if they can afford to wait for the agency to issue any parameters for operating in this environment or they forge ahead and hope for the best.  At this point, you must decide if you shape the environment, or you let it shape you.

It’s a worrying rallying cry, considering that these companies aren’t selling refrigerators – they’re selling life-changing and lethal substances.

–Kate Petersen, PostScript blogger

‘Marketplace’ (American Public Media) takes a look at what some states are doing to combat pharmaceutical sales reps influence on prescribing, and help get doctors the best evidence–without the sales pitch.

‘Marketplace’ followed “academic detailers” employed by the state of Pennsylvania as they visit with physicians. Tom Snedden, the director of the program, which employs 11 academic detailers–often nurses or pharmacists–said the program was small but effective in improving quality and reducing unnecessary costs.

“The industry’s trying to sell a product. What we’re trying to sell is clinically-appropriate prescribing,” he said. “Since the program began in 2005, the doctors who have met with academic detailers have prescribed fewer brand name drugs and fewer drugs overall.”

Other states have taken their cue from Pennsylvania since it implemented it’s academic detailing program 5 years ago. Three New England states are sharing best practices and resources in a regional academic detailing initiative. Legislation has passed in four states and D.C., while three additional programs were implemented by state Medicaid agencies.

This session in Wisconsin, Rep. Chuck Benedict has introduced an academic detailing bill, which is backed by the broad group of supporters, led by the Coalition of Wisconsin Aging Groups. The bill will be heard in a joint public hearing on prescription drug reform in March.

And in Minnesota, academic detailing legislation is being considered as part of a prescription reform package. The bill (Sen. Sheran) backed by the newly-formed Minnesota Prescription Coalition, has cleared two key committees in the Senate and is now before the Finance Committee; a House counterpart (Rep. Liebling) is due to be heard by the House Health Policy Committee in early March. (More information at the coalition website)

Because of the success of such programs at the state level, development of a federal prescriber education program is underway.

Wisconsin Sen. Herb Kohl, Chair of the Congressional Special Committee on Aging, sponsored the federal Independent Drug Education and Outreach Act of 2009.

And the Obama administration and Agency for Healthcare Research and Quality have demonstrated support for this approach, too, including academic detailing as an example of an intervention to promote the adaptation and dissemination of comparative effectiveness research products in a request for proposals the Agency posted in September, 2009—a new round of AHRQ grants was announced last week as well.

Listen to the full Marketplace story, or learn more about prescriber education at Prescription Access and Quality and the Pew Prescription Project.

–Kate Petersen, PostScript blogger

In his health care reform proposal to Congress and the nation revealed today, President Obama has included requirements for pharmaceutical and medical device companies to disclose payments to health care providers and hospitals. These ‘Sunshine provisions,’ modeled after a bill introduced in the Senate in 2007 by Senators Herb Kohl and Charles Grassley, have bipartisan, bicameral support, and were included in the health care reform bills passed by both the House and Senate this winter.

Here’s the language:

To prevent conflicts of interests and insure full transparency and information for patients, the Act requires all drug companies, device, and medical supply manufacturers to fully disclose and report any gifts they make or financial arrangements they have with doctors, a physician practice or group.

The proposal, released ahead of a much-awaited bipartisan health care reform summit at Blair House this week, reflects a growing national consensus about the need for robust transparency of the financial relationships between providers and the pharmaceutical and device industries, including recommendations by the Institute of Medicine and the Medicare Payment Advisory Commission.

The President’s health care reform proposal also requires pharmacy benefit managers to disclose information about negotations and drug pricing deals they make, a component of the original House bill passed in November.

President Obama’s proposal goes beyond the Senate bill on prescription drugs in two other important ways:  closing the Medicare Part-D ‘doughnut hole,’ and banning pay-for-delay settlements that keep drug costs artificially high.

By closing the doughnut hole, the President’s plan would save the 8 million seniors who exhaust their prescription drug benefits each year an average of $4,080 a year by 2020. Like today, seniors will still have a 25 percent co-insurance obligation until ‘catastrophic’ coverage kicks in, unless they qualify for low-income subsidized coverage.

The proposal also grants the Federal Trade Commission the authority to police drug company patent settlements for “collusion” to keep generics off the market. FTC estimated that such a reform would save $35 billion over the next decade, and Obama’s proposal would give FTC the authority to prevent these settlements unless proven to increase competition.

–Kate Petersen, PostScript blogger

In her testimony before the House Energy and Commerce committee on health appropriations, HHS Secretary Kathleen Sebelius called for $101 million of FDA’s 2011 budget request to be used for a “medical product safety initiative” to increase inspections and “invest in tools that will enhance the safety of increasingly complex drugs, medical devices, and biological products.”

We are glad to see the Secretary recognizing the need for increased inspections –  the lack of foreign inspections is a  problem highlighted recently by FDA itself and the GAO, which found that FDA is able to inspect just seven percent of prioritized foreign drug manufacturing sites every year. This, despite evidence that foreign India and China alone produced close to 70 percent of the global supply of active drug ingredients in 2007 – up from just under half of the APIs three years before.

Doing the math, that means plants making U.S drugs overseas may wait well over 10 years between FDA inspections, while domestic plants are inspected every 2.7 years on average.   The rate of inspection within China is even lower. If unchanged, it would take nearly 50 years to inspect all 700 or so FDA-registered Chinese drug-manufacturing sites.

Recent increases in budget appropriations for FDA have allowed the agency to begin to build its foreign inspections program, as well address structural problems at the agency like understaffing and IT capacity.  But serious structural problems affecting the agency’s ability to regulate drug manufacturing and importation remain.  And considering the growth rate of foreign manufacturing plants and how thinly resources must be stretched.  The increased appropriations the Secretary recommends will likely still be insufficient to bring foreign inspection up to speed with domestic inspection rates.

One way to help correct for this would be to consider a user fee system as proposed in legislation introduced in both the House and Senate in the current Congress. The agency already employs user fees with drug manufacturers during the approval process, and with food and drug companies whose manufacturing violations require re-inspection. A similar user fee for general Good Manufacturing Practice (GMP) inspections inspections would help protect consumers.

Inspections alone are not the solution. FDA must find better ways to predict risk. And the agency is taking steps. For example, at the border, the agency uses  PREDICT, a new web-based risk-based assessment system that incorporates inspection histories, counterfeit risk, and environmental influences. But such a system could also be used earlier in the inspection process, to target overseas manufacturing inspections before risky products ever get shipped or unloaded at the docks.

–Kate Petersen, PostScript blogger

As Cephalon joins the ranks of pharmas disclosing payments to physicians or health care entities under corporate integrity agreements, John Mack at the Pharma Marketing Blog and Eric Milgram over at Pharma Conduct have good posts on the importance of the format in which companies have posted data about who’s getting what.

In a distinction Mack describes as translucent vs. transparent, Cephalon’s payments are posted in FlashPaper, a format that does not allow the data to be copied and is hard to search. So are Eli Lilly’s, which began disclosing under a similar agreement late last year. Merck and GlaxoSmithKline, who began disclosing some payments (these were not court-ordered disclosures) last month, publish the data in PDFs, which are unsortable and hard to search, but at least allow data to be extracted.

All the companies fall short in that they provide little or no additional detail on the nature or purpose of the payments. Merck only reports payments to U.S.-based health care professionals who speak on behalf of Merck or its products through Merck Medical Forums, presumably excluding payments to providers who provide other types of services.  And no companies have provided complete disclosures that include all those paid for clinical trials and every type of research, although GSK plans to begin reporting compensation to research investigators in 2011.

Eric Milgram’s checklist for what details make disclosure data usable and valuable to the public is a great place to start. He says at minimum, disclosure data should include a provider’s name, specialty, main hospital or practice affiliation, and a brief description of the reason for payment.  And he says that companies shouldn’t only have to disclose those payments made to physicians, but to all health care providers.

The lesson in all this? When it comes to disclosure, details matter. The program Cephalon and Lilly have used to date make searching difficult and copying impossible. There are easier programs out there: it’s time to use them. Without useful markers—(it’s not as helpful to search for a doctor by the letters in her name if you can’t also search by state, specialty, or practice location)–it’s difficult for consumers and researchers to use the data to make informed decisions or analyze trends in industry-physician relations—arguably the very reason such disclosures are part of court settlements.

These first disclosure attempts provide good lessons for courts that wish to make meaningful disclosure a part of future settlements, as well as state and federal regulators who are developing or may have to plan for uniform disclosure databases such as those proposed in the Physician Payment Sunshine provisions and bills being introduced in several states this year.

As a postscript, it’s worth remembering that despite the good publicity some pharmas have gotten for putting this data on their websites “voluntarily” (see: Eli Lilly), half of the companies that have disclosed payments so far (and more than half, if you count medical device companies) have done so by order of a court because they settled on charges of systematic inappropriate marketing – cases that have yielded enlightening documents about company marketing practices and their sway over company research, authorship, and publication.

–Kate Petersen, PostScript blogger

-by Michele Kimball, state director, AARP Minnesota

At the Minnesota State Capitol today, lawmakers are hearing about important proposals to reform the way prescription drugs are prescribed in Minnesota.  AARP is pleased to be part of the Minnesota Prescription Coalition working to help this effort gain the attention it deserves  — and to ultimately pass these important reforms.

Why do we care?
AARP represents about 700,000 consumers in Minnesota over the age of 50.  It comes as no surprise that older Minnesotans have a huge stake in this game because they are the biggest consumers of prescription drugs.

Prices of drugs continue to rise, having a direct negative effect on older and disabled Americans, especially those on fixed incomes. These are the Minnesotans who won’t receive a Social Security cost-of-living increase in 2010 because of low inflation of nearly every other sector of the economy.

Higher drug prices mean that Minnesotans enrolled in Medicare’s Part D drug program more quickly reach the “doughnut hole”—the coverage gap in which they must currently pay the full price of their medications.  To be sure, older consumers want policymakers to do whatever they can to control costs.

But it’s not just about drug costs.  It’s about quality, ethical health care – and about ensuring that our loved ones get the right drug and the right information whenever they visit a doctor.

Kim Witczak’s Story
No one can speak to this issue better than Kim Witczak, a very brave consumer from Minneapolis who has become an expert on prescription drug issues since the death of her husband.

On August 6, 2003, Kim’s husband, Woody died of a Zoloft-induced suicide at age 37. He was not depressed, nor did he have any history of depression or any other mental illness. He died after taking the drug a total of 5 weeks with the dosage being doubled shortly before his death. He was given the antidepressant from his general physician for “insomnia.”

Kim told Minnesota’s lawmakers that Woody loved life. He was a compassionate, loyal husband, son, brother, uncle, godfather and friend. He had endless energy, a constant smile and a laugh that could be heard a mile away. Woody had a successful sales career and had just started his dream job as VP of sales with a start up company. He was excited about this new opportunity and along with this excitement came difficulty sleeping. He went to see his family doctor and after a 5-minute consultation, he was given Zoloft for an insomnia diagnosis.  This was the first time he’d ever gone to a doctor for this sort of issue.   Read more about his story at www.woodymatters.com.

Kim talked about the current way we prescribe drugs and how Woody and his doctor became victims of a system that is too focused on marketing and profits.  Woody was given a 3-week sample of Zoloft by his general practitioner.  Insomnia is an “off-label” use for Zoloft.  Samples are a marketing technique used to promote drugs.

Marketing and Detailing

Too much of the information and research that doctors get about the drugs they prescribe comes from the drug companies’ representatives.  As Allan Coukell of the Pew Prescription Project testified today, spending on marketing and promotional goods by the pharmaceutical industry is estimated at nearly $30 billion – much of it directed at those who prescribe medications.  Drug reps visit the office to discuss the attributes of the drugs and to leave samples.  In fact, between 60-80 percent of all antidepressant prescriptions are written after about a 5-10 minute consultation by general practice or family doctors who may or may not know the significance of all the side effects.

From a consumer’s perspective, educating doctors about new drugs should not be left to marketers.  Doctors need nonbiased information and they need all the research available to know the risks of what they are prescribing.  Patients need to know that their health care providers are delivering the best care possible and that they are not swayed by gifts or other financial incentives.

Marketing and sales practices have no doubt compromised the doctor-patient relationship and have contributed to the skyrocketing costs of prescription drugs and the overall increase in health care costs.

So What Happened Today?
The Minnesota Prescription Coalition and key legislative authors presented three bills today to help reduce the current conflicts or interest between pharmaceutical industry and doctors.

• Legislation that will prohibit pharmaceutical companies from buying doctors’ prescribing records and using the information to target their marketing to individual doctors. Pharmaceutical Data Mining: S.F. 1044 (Sen. John Doll) and H.F. 491 (Rep. Tina Liebling)

• Legislation that will ban gifts to providers from pharmaceutical manufacturers and improve transparency and reporting laws that more clearly define relationships between health care providers and pharmaceutical companies. Pharmaceutical and Medical Device Gift Ban:  S.F. 1237 (Sen. John Marty) and H.F. 1641(Rep. Tina Liebling)

• Legislation to establish an “academic detailing” program to give physicians nonbiased information to make the best and most cost-effective decisions about prescriptions. Independent Prescriber Education Program “Academic Detailing” S.F. 895 (Sen. Kathy Sheran) and H.F. 1640 (Rep. Tina Liebling)

I believe that momentum is growing in Minnesota among consumers, providers and policy experts to establish objective, evidence-based methods of getting accurate information into the hands of physicians and other prescribers.

Dr. Chris McCoy, a physician in Rochester, and policy chair of the National Physicians Alliance spoke about how many doctors feel about the current marketing practices of pharmaceutical companies.  “Trust in the medical profession is slipping away as pharmaceutical companies buy influence through our systems,” said McCoy.  “Families and patients need to trust that doctors are making the best decisions, based on nonbiased information.”

I can tell you from my experience in conversations with AARP members here in Minnesota, frustration about the negative effects of the pharmaceutical industry’s marketing practices is at an all-time high.

We still have a lot of work to do.  The opposition to this legislation is out in force.  I believe that eventually, these bills will prevail.  Minnesotans are a very common-sense lot.  These bills make common sense for consumers, health care providers, insurers and government entities in Minnesota.

Yesterday, the FDA unveiled ‘FDA Basics’, a website tool geared to help the public get to know the FDA staff and what they do. The website will provide explainers to questions about what the agency and its different centers do, videos and profiles of agency leaders, as well as hosted online conversations between FDA officials and the public.

FDA Basics is the first of a three-part transparency initiative that the agency is undertaking under the Obama administration.  In a webinar Tuesday, deputy commissioner Joshua Sharfstein said the Basics site grew out of unsolicited public feedback to the transparency task force seeking more info about how the agency works.

But the site won’t offer the clinical safety and efficacy information on specific drugs that many consumer advocates have called for. That, Sharfstein said, is part of daunting phase two, in which the agency will make recommendations about what information should be made public and accessible  and how — including clinical trials information, recalls, approval and warning letters, and post-market surveillance.  Recent reports (see our blog last week) have highlighted the unavailability of this information to prescribers and the public–even about some of the top-prescribed drugs in the U.S.

Phase three will establish how the agency interacts transparently with regulated industries.

Sharfstein commended the tremendous feedback the agency received on the FDA transparency blog and at the task force’s public hearings, and invited more on the FDA Basics website. In response to a webinar question, he also said that the site should provide information about how to become an advisory committee member for the agency.

Check out FDA Basics here.

–Kate Petersen, PostScript blogger

A review by the Sunlight Foundation found that important safety and other clinical data on more than one-third of the top-prescribed drugs in the U.S. is  not readily available to prescribers, researchers and patients. The transparency watchdog group found that nine of the 25 top-prescribed drugs, including Lipitor, Effexor, and Plavix, lack this online information–meaning most prescribers have an incomplete picture of safety and efficacy on commonly-written scrips.

The data, required by the FDA for approval but often left unpublished in medical journals and other venues, is only online for drugs approved after 1998. Even then, Sunlight reports, the online info may be heavily redacted and is published in manually-created PDFs that “are not hyper-linked or text searchable, and therefore are hard to navigate.” Information on drugs approved before 1998 has to be obtained by the characteristically slow and cumbersome Freedom of Information Act request, a process most physicians don’t use to inform prescribing decisions.

The Foundation says its unclear whether such data will be included as part of the Obama administration’s Open Government Directive, a plan to have each government agency publish previously undisclosed data sets to the public, but drug safety advocates like Dr. Steven Nissen of the Cleveland Clinic say that such drug info should “absolutely” be included.

For more on the review, including a list of the top-prescribed drugs and which data remains inaccessible, read the story here.

–Kate Petersen, PostScript blogger

In a look both back and ahead at the relationships between the pharmaceutical and medical device industry and physicians, Modern Healthcare reports today that transparency has come a long way in the last three years, but there’s still a ways to go to “ensure patient care is free of financially induced bias.”

When the Senate began investigating the issue of payments from pharma and medical device companies to physicians three years ago, many in the industry denied there was a problem, writes Modern Healthcare.  “But now the healthcare industry appears poised, even if reluctant, to remove the veil that has cloaked industry-provider financial ties. An increasing number of provider organizations, medical-device companies and drugmakers have begun voluntarily disclosing those relationships, and the proposed Physician Payments Sunshine Act, which would mandate disclosure, may soon become law as part of Congress’ healthcare overhaul.”

Indeed, major drugmakers like GlaxoSmithKline and the medical device trade organization AdvaMed actively support the Senate bill, which is moving through the health care reform process now. And a number of companies, including GSK, have pledged to voluntarily disclose payments made to physicians and medical groups.

The Pew Prescription Project’s Allan Coukell and other supporters of the Physician Payments Sunshine provisions say that such voluntary disclosure efforts are no stand-in for a uniform and comprehensive transparency law like the Sunshine proposal.  “We’re nowhere near comprehensive disclosure,” Coukell said, “and if you do it company by company the information is not that useable.”

Harvard researcher Eric Campbell concurred, telling Modern Healthcare that when it comes to disclosure, details matter. “The real question is the level and depth of disclosure,” Campbell said, adding that penalties for non-compliance must be significant enough to encourage companies to collect and report the information.

For more about the Physician Payments Sunshine provisions, check out the RxP Sunshine Guide.

–Kate Petersen, PostScript blogger